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LIFE SCIENCE COMPLIANCE
Aims
The aim of the Journal is to provide factual information and case studies regarding all aspects of Compliance for companies operating in the Life Sciences sector across Research & Development, Manufacturing, Sales & Marketing and Corporate activities to inform compliant decision-making across the Life Sciences sector.
The initial focus for the first few issues of the journal will be Sales & Marketing compliance, as this is currently the highest risk area for companies.
Scope
The scope will include:
Regulations, laws and industry body codes of practice governing all aspects of the Life Sciences sector, including anticipated changes,
Case studies of how companies have complied with the legal, regulatory and code requirements, including practical suggestions for improvements and potential technology solutions,
Reporting on sanctions imposed on companies for various non-compliant activities, including implications for other companies and what could have been done differently,
Independent reviews of services and technologies available to help keep companies compliant.
Main topics
Interactions with healthcare professionals
Fee for service arrangements, including clinical trials
Sponsorship to attend meetings and conferences
Meetings and hospitality
Gifts and marketing materials
Market research
Independence of prescriber decisions
Interactions with other government officials and decision-makers (e.g. health ministers, formulary decision-makers, payers)
GxPs
Good Laboratory Practices
Good Clinical Practices
Good Manufacturing Practices
Good Distribution Practices
Grants and donations
Data protection and privacy, particularly around implementation of company hotlines
Use of electronic media in the marketing mix, e.g. Facebook, twitter, micro-sites, etc.
Audience
Compliance officers,
Managers in the key functions of Research & Development, Manufacturing, Sales & Marketing and Corporate divisions, e.g. Clinical Trials Managers, Sales Managers, Distribution Managers, etc.),
Internal auditors,
Risk managers,
Ethics officers,
Corporate social responsibility managers,
Consultants,
Lawyers.
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